Document and Labeling Administrator Job Locations US-OH-Cincinnati Company Meridian Bioscience, Inc. Department Quality & Regulatory Affairs

of Openings

1 About Meridian Meridian Bioscience is a fully integrated life science company that develops, manufactures, markets and distributes a broad range of innovative diagnostic products. We are dedicated to developing and delivering better solutions that give answers with speed, accuracy and simplicity that are redefining the possibilities of life from discovery to diagnosis. We are looking for talented and passionate individuals that help drive our vision. Our innovative culture will allow interested candidates to discover and create, through collaboration, cutting edge solutions to tough problems. Job Summary Responsible for word processing and coordination of activities for document and labeling creation, implementation, and archiving. Perform all task in compliance with the company's quality system requirements. Key Duties Tasks/Duties/Responsibilities: Prepare procedures, forms, specifications and labeling in MasterControl Review ECO and documents for accuracy, approve and reject tasks, and notify initiator/author when training can be completed. Prepare and launch ECOs and associated documents in MasterControl. Track and maintain the required company regulatory licenses and registrations, including but not limited to, FDA, ISO EPA, USDA, Louisiana Board of Drug and Device Distributors, etc. Performed required tasks to keep licenses and registrations current and not expired. Maintain the hard copy archives of Meridian documents. Assist in the design and implementation of e-forms in MasterControl. Assist in the preparation of regulatory submission documents including electronic 510(k), Pre-IDE, CFG, etc. Work with MIS to load and unload labeling, MSDS sheets etc. from company website. Maintain controlled access library of completed Validations, Investigations, Product Registrations, Design History files and Clinical Trials (where appropriate load to file server or maintain and update indexes). Maintain records and indexes of all documents stored off-site. Coordinate off-site storage and retrieval of documents, pick up of shred bins, ordering of storage boxes, barcode labels, inventory sheets and records for all departments. Assist in annual audit of document management Storage Company. Assist all personnel in troubleshooting document related problems and creation of info cards and ECOs in MasterControl. Provides guidance to other departments with respect to document formats and use of MasterControl. Assists with preparation of regulatory submission documents. Run Superseded Document Report from MasterControl. Retrieve, suspend and/or archive old files and refile. Assists RA/QA, R&D and Marketing employees in the preparation of product labeling including layouts, translations, updating technical files, updating label specifications and print proofs/films. Generate labeling as required including package inserts and operator manuals. Assist in maintaining the EC PROD REGIS folder and documents. Coordinates the preparation of device master records, procedures, forms, technical files, validation documents, specifications, etc. in MasterControl for RA/QA departments. Supports Meridian's Quality System and compliance with requirements of 21 CFR 820, 21 CFR Part 11, ISO13485 and applicable standards or guidance, as appropriate to assigned tasks. Other duties as assigned. Other Duties/Physical Requirements: Physical Ability to walk up and down several flights of stairs throughout the workday in a multi-location facility. Ability to sit for long periods of t